GBU: High-intensity focused ultrasound, or HIFU, is a minimally invasive way of delivering tissue ablation. HIFU uses ultrasound energy focused at a very high level to destroy tissue. And it's extremely precise. Because of HIFU's precision, this treatment spares patients' erectile and continence mechanisms—mechanisms that are often affected during other treatment modalities. HIFU was first used in the treatment for prostate cancer in Europe in 1993. In October 2015, the FDA approved it as a treatment option in the US.

Q: Can you tell us a little more about HIFU's history?

GBU: The theory behind using energy goes back to shockwave lithotripsy for kidney stones. Scientists and physicians saw how focusing energy could break up kidney stones and wondered if it might be possible to use a different form of energy to destroy tissue, specifically cancer cells. Ultrasound was chosen because ultrasound can be delivered non-invasively and because you can image at the same time, meaning we can actually see the tissue that we're destroying as we're destroying it.

Q: Who's a good candidate for HIFU?

GBU: Almost anybody is a good candidate. All prostate cancer can be treated with HIFU, although advanced cancers may require additional modalities or therapies. But no one is excluded except for the very few patients who have severe latex allergies or they have severe rectal wall thickening. But otherwise, everybody is a candidate.

That would include patients who have failed other types of prostate cancer treatments, including those who have failed radiation, external beam radiation, and radiation by implantation of prostate cancer seeds. Or patients who have failed treatments by cryoablation or freezing of the prostate. Also patients who have been on active surveillance are very good candidates for undergoing treatment with HIFU because the cancer can be ablated in a non-invasive fashion. Then, the patient would no longer have to worry about the cancer growing and spreading during the time of surveillance.

Q: Can you discuss the benefits?

GBU: One of the big benefits of HIFU is the precision in which the energy is delivered. The precision parallels that of a surgeon cutting out the tumor. Another benefit: with HIFU, we can opt to treat only a portion of the prostate gland. For example, if a patient has cancer localized on one side, we can leave the normal side alone. And the patient will still have very little risk of erectile dysfunction or voiding dysfunction afterwards. We can also treat the whole gland more precisely while still sparing the nerves of erection.

No procedure is perfect and no procedure is going to cure prostate cancer in 100% of people, but HIFU is as effective in those realms as surgery. And surgery is definitely more effective than radiation. So HIFU is one of the best modalities for treating prostate cancer. It's less invasive, it's an outpatient procedure that takes somewhere between 1-3 hours, and it offers an excellent cure rate with minimal complications.

Q: Are there any downsides?

GBU: All procedures have potential complications. But complication rates with HIFU in European studies were very low. In the very early studies, there were definitely slightly higher rates as they were perfecting the machines, the first prototype. They had to learn how to adjust the machine and how to deliver the therapies more effectively and more safely, but at this point, the complication rates of HIFU are far below surgery and radiation both.

Q: Let's discuss the procedure itself.

GBU: There's not a whole lot of preparation for HIFU. The patient would be prepared the day before with an enema. On the day of the procedure, the patient will undergo a general anesthetic, although they can opt for a spinal anesthetic. They go to sleep. They lie on their right side in a very comfortable position. A small probe is inserted in the rectum, which does both the treatment and the imaging all in one probe. There's also a catheter in the bladder.

Once the treatment is delivered, the patient wakes up and goes home with a catheter for usually a few days to help prevent urination problems after the procedure because of swelling of the tissue.

Afterwards, the patient might expect to see a little blood in the urine from time to time, and after the catheter comes out, they'll possibly pass a little bit of the ablated tissue. But there's very little pain, very little discomfort, and after a week or two, patients feel normal.

GBU: In general, we check the patient's PSA every three months, and I encourage each patient to have a biopsy in a year to see if there's any residual cancer. Recent long-term studies suggest a 95% cure rate in those patients who have been re-biopsied. And if the HIFU treatment failed, for whatever reason, patients can have another HIFU treatment, which is unusual (it's rare that a treatment can be "repeated"). Luckily, it's a very tiny percentage of patients who will fail the treatment.

Q: Where do insurance agencies currently stand on HIFU?

GBU: To date, the Centers for Medicare & Medicaid Services (CMS) has not given a code to HIFU, so there isn't coverage up front, in general. However, we've understood that patients have been able to get coverage in retrospect from their insurance companies. For now, it's between the patient and their insurance company. But we're hoping to see this change. I would expect we'll see a code for HIFU in the next two years and that Medicare will reimburse for it. After all, HIFU is much more cost-effective than radiation or surgery. In fact, it's more effective in the short-term and long-term.

Q: Is there anything else you'd like to mention?

GBU: Our thinking about prostate cancer has evolved significantly over the years. This is a disease that can be managed and that men can live with for decades or their entire lives. Just like other chronic diseases, such as high blood pressure or diabetes, we can manage prostate cancer without putting the patient through something that's going to change his quality of life to the point he is unhappy. We try to preserve quality of living and manage the disease so that this doesn't become a problem. HIFU is a perfect tool for that.

As such, HIFU should always be included in the discussion. Many physicians are either not informed about HIFU or they don't recognize it as a legitimate treatment, probably because they don't know enough about it. Patients should initiate the discussion with their own physician and seek out opportunities to get fully informed about HIFU before they make any decision on treatment of prostate cancer. I think it's well worth considering for everybody.